Oklahoma Administrative Code
Title 310 - Oklahoma State Department of Health
Chapter 2 - Procedures of the State Department of Health
Subchapter 31 - Human Subjects Protection
Section 310:2-31-26 - Conducting the investigation

(a) Purpose of the investigation. The purpose of the investigation is to explore in detail the allegations, to examine the evidence in depth, and to determine specifically whether misconduct has been committed, by whom, and to what extent. The investigation will also determine whether there are additional instances of possible misconduct that would justify broadening the scope beyond the initial allegations. The findings of the investigation will be set forth in an investigation report.

(b) Sequestration of the research records. The RIO will immediately sequester any additional pertinent research records that were not previously sequestered during the inquiry.

(c) Appointment of the Investigation Committee. The RIO, in consultation with other OSDH officials as appropriate, will appoint an investigation committee and the committee chair within ten(10) days of the notification to the respondent that an investigation is planned or as soon as practicable. The makeup of the investigation committee will follow the same requirements outlined for the inquiry committee. Individuals appointed to the investigation committee may also have served on the inquiry committee. The RIO will notify the respondent of the proposed committee membership within five (5) days. If the respondent submits a written objection to any appointed member of the investigation committee or expert, the RIO will determine whether to replace the challenged member or expert with a qualified substitute.

(d) Charge to the committee. The RIO will define the subject matter of the investigation in a written charge to the committee that describes the allegations and related issues identified during the inquiry, defines scientific misconduct, and identifies the name of the respondent. The charge will state that the committee is to evaluate the evidence and testimony of the respondent, whistleblower, and key witnesses to determine whether, based on a preponderance of the evidence, scientific misconduct occurred and, if so, to what extent, who was responsible, and its seriousness. During the investigation, if additional information becomes available that substantially changes the subject matter of the investigation or would suggest additional respondents, the committee will notify the RIO, who will determine whether it is necessary to notify the respondent of the new subject matter or to provide notice to additional respondents.

(e) Investigation process. The investigation committee will be appointed and the process initiated within 30 days of the completion of the inquiry and the determination that an investigation is warranted. The investigation will involve examination of all documentation including, but not necessarily limited to, relevant research records, computer files, proposals, manuscripts, publications, correspondence, memoranda, and notes of telephone calls. Whenever possible, the committee should interview the whistleblower(s), the respondents(s), and other individuals who might have information regarding aspects of the allegations. Interviews of the respondent should be tape recorded or transcribed. All other interviews should be transcribed, tape recorded, or summarized. Summaries or transcripts of the interviews should be prepared, provided to the interviewed party for comment or revision, and included as part of the investigatory file.